About the BAA

What is the BARDA Broad Agency Announcement (BAA)? As noted in the Federal Acquisition Regulation (FAR), BAAs may be used by agencies to fulfill their requirements for scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding rather than focusing on a specific system or hardware solution.

The BARDA Broad Agency Announcement, or BARDA BAA, is used to solicit proposals for the advanced research and development of medical countermeasures for chemical, biological, radiological, nuclear agents, pandemic influenza, and emerging infectious diseases that threaten the U.S. civilian population.

BARDA anticipates that research and development activities awarded under this BAA will serve to advance candidate MCMs toward FDA licensure or approval.

This BAA will also serve to advance the knowledge and scientific understanding of candidates' platform technologies, modeling and forecasting, and visual analytics.

Where can I find the BAA and updates to the BAA?Updates and changes to the BAA are available via FedBizOpps.gov.

Who is eligible to submit a proposal to the BAA? Single entities or teams from private sector organizations, government laboratories, and academic institutions are eligible to submit a proposal.

Can I submit a Full Proposal without first submitting a White Paper?Eligible offerors are permitted to skip the White Paper process and submit a Full Proposal.

However, BARDA encourages offerors to submit a White Paper first because it provides to BARDA an overview of the proposed concept and the offeror’s capabilities. BARDA can review the White Paper to determine if the proposed concept is within its mission space before an offeror invests the expense of developing a Full Proposal.

BARDA understands that preparing a Full Proposal is expensive. Preparation of a White Paper is less time- and cost-intensive to offerors and provides BARDA staff with an opportunity to rapidly provide feedback on the relevance and technical merit of a potential project.

Can an offeror who is not based in the U.S. submit a proposal to the BAA?Yes.

Definitions

What is a regulatory plan and what information should it include?A regulatory master plan outlines the activities necessary to obtain FDA approval or clearance of the product. For in vitro diagnostics (IVD) and medical devices, this is typically a 510k clearance.

The plan should cover the crucial development pathway, integrating all products, risk evaluation, and mitigation at all development stages; non-clinical and clinical testing; and manufacturing activities using the most current and available information, including documented and time-relevant consultation with FDA.

The plan should also include a tentative schedule for regulatory milestones. For more information, see:

What are Technology Readiness Levels?Technology Readiness Levels (TRLs) provide a common set of definitions for determining the progress of research nad development (R&D) programs in the field of medical countermeasures. The TRLs allow a R&D program to be classified by its degree of maturity from basic research to post-licensure and post-approval activities.

Awards and Funding

Can you verify that funding is available for a particular period?Actions under the BARDA BAA are always subject to the availability of funds.

What factors influence the potential value of anticipated awards? The award dollar value is dependent on several factors, such as funding availability, cost/price overall best value to the government, innovation presented, viability of concept and/or approach, and alignment with BARDA priorities. To learn more about BARDA’s goals and priorities, see the BARDA Strategic Plan.

How accurate do cost estimates need to be for White Paper submissions?For White Papers, BARDA requests that offerors submit their best high-level estimate of the total cost of the work based on realistic timelines and program activities necessary to accomplish the objectives of the scope of work proposed.

Can BARDA fund a proposal that includes support from other federal agencies involved in the research?The BARDA BAA is open to all responsible sources, including single entities or teams from the private sector, government laboratories, academic institutions, Federally Funded Research and Development Centers (FFRDCs), and government entities (government/national laboratories, military educational institutes, etc.).

However, there must be no overlap in funding. You cannot include government entities in the same manner that you would subcontractors or consultants, with respect to your expected contract award value.

If any government entities are part of your proposal, please include how they fit into your proposal. Do not include those amounts for any government entities in your proposed budget.

Is there any preferential treatment in your selection process for small businesses?The BARDA BAA is issued under paragraph 6.102(d)(2) of the FAR, and proposals selected for award are considered to be the result of full and open competition. Small businesses are encouraged to submit proposals and join other entities as team members in submitting proposals.

Communicating with BARDA

How do I contact someone to discuss my future proposal to ensure that it is responsive to the BAA?BARDA recommends that you first register for a TechWatch meeting for an opportunity to present your capabilities before submitting a White Paper of Full Proposal.

Offerors who participate in a TechWatch meeting prior to responding to the BARDA BAA have a better understanding of BARDA’s priorities and are able to benefit from the strategies and other information discussed during the TechWatch meeting.

However, a TechWatch meeting is not required.

How do I contact someone with specific questions about my proposal before submission?You may direct technical and contracting related questions to the points of contact in your specific area of interest before drafting or submitting your White Paper or Full Proposal.

After a White Paper or Full Proposal has been submitted, all communications related to that submission must go through a Contracting Officer.

Are communications with BARDA permitted after a White Paper or Full Proposal submission?All communications related to a particular submission must go through the Contracting Officer.

If I have not received a response regarding my submission after the allotted review time has ended, who can I contact to learn more about the status of my submission?​​After you submit your proposal, you should hear back from an the Contracting Officer in the following timeframes:

White Paper: 90 calendar days from the submission deadline

Full Proposal: 90 calendar days from date your proposal was received

If you have not received a response in those timeframes, please contact the the Contracting Officer for your area of interest.

Technical

Which MCMs is BARDA most interested in pursuing?BARDA is most interested in the MCMs listed in the BARDA BAA areas of interest​.

Is there a preferred level of risk?While BARDA does not have a preferred level of risk, the evaluation of any White Paper or Full Proposal submission will consider the potential of developing a product that is FDA approved and can be manufactured and used routinely or in an emergency.

Is there value in having commercial partners with potential products as part of the proposed effort? Yes. Commercial partners can provide financial and organizational stability to smaller organizations while they pursue medical countermeasure development activities.

How much data should be included in the White Paper given its page limitation?Offerors should submit as much relevant data and details in their White Paper as possible, utilizing any method allowed by the BARDA BAA (see page 58 - Quad Chart and White Paper Submission) to convey the information effectively.